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Compliance In Focus
Posted by Victoria Sawczak on Tue, Jun 7, 2016

The Real Costs of Clinical Research

The_Real_Cost_of_Clinical_Research.jpgIn 1996 The University of Rochester was offering $150 to volunteers for what was designed to be a minimal-risk research study. To 19-year-old Nicole (Hoiyan) Wan, a hundred and fifty dollars meant being able to afford a trip home to see her parents in Queens, New York. Nicole, like many college students, found the money offered on a campus flier for participation in the clinical research study to be extremely enticing. Back in Queens, New York, Mr. and Mrs. Wan were unaware of their daughter’s intention to enroll in any study.

The study was focused on the mechanism by which the lungs defend against infection and pollutants. Participants underwent a bronchoscopy that allowed researchers to retrieve a sample of lung cells. This routine procedure was initiated by administering up to 5 milligrams per milliliter of an anesthetic called Lidocaine, per the original approved protocol submitted in 1981. At the hands of an inexperienced intern, Nicole Wan reportedly received 9 milligrams per milliliter of Lidocaine. Further, a New York Times article indicated that despite claims of severe pain and weakness, Wan was discharged following her study procedure. She died two days later from cardiac arrest attributed to the lethal level of Lidocaine revealed in her blood.

The tragic and untimely passing of Nicole Wan prompted an onset of ethical questions regarding clinical research:
  • Should invasive clinical research procedures have more stringent age requirements?
  • Should they be required to follow the same FDA guidance (Table 1) that has been developed for clinical research devices in pediatrics?
  • Is it ethical to advertise compensation-based research studies to college students between the ages of (18-21) considering the average student’s financial circumstances?
  • Are those conducting the research procedures equipped with the proper training?
  • Are the researchers’ training/credentials being routinely monitored?

Table 1:

Pediatric Subgroup Approximate Age Range
New born (neonate) From birth to 1 month of age
Infant Greater than 1 month to 2 years of age
Child Greater than 2 to 12 years of age
Adolescent Greater than 12 through 21 years of age

The above is the most current FDA guidance describing pediatric populations divided into the listed subgroups.

Clinical research studies are essential for the progression of human health. The foundation of this progression is entirely dependent on the willingness of brave participants like Nicole Wan. It is the responsibility of all research personnel including the sponsors, investigators, auditors and monitors to ask the right questions. The principles of ICH GCP state that “The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interest of science and society.” What questions were not asked that led to the preventable death of Nicole Wan?

In Vitro Diagnostics

photo credit: stethoscope via photopin (license)

Topics: New York Times, Clinical Research, Nicole Wan

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